Medonic M-Series Hematology Analyzer M16S BD ABR US Product code:… — Class II medical device recall Z-1001-2020
Terminated recall by Clinical Diagnostic Solutions, Inc., reported 2020-02-12, distributed nationwide. A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of
| Recall number | Z-1001-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clinical Diagnostic Solutions, Inc., Plantation, FL, United States |
| Recall initiated | 2020-01-02 |
| Classified | 2020-02-05 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2022-11-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, IT, UA, VE |
| Quantity | 261 |
| Model numbers | 1400011, 1400075 |
Product
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
Reason for recall
A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1001-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.